Current Studies

The Research Department is currently conducting studies in the following areas:

Linaclotide for constipation-predominant IBS

FMT for chronic active UC - FOCUS study

Differences in gut bacteria of patients with CDI or UC before and after FMT

Dietzia C79793-74 in Crohn’s disease

If you are interested in more information about the studies listed above, or would like to know about upcoming studies please call us on (02) 9713 4011

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Department of Research and Innovation

Clinical Trials - What are they?
Why do we need them?

What is a Clinical Trial?

Why are Clinical Trials so important?

How are Clinical Trials conducted?

A clinical trial falls into one of four phases:

Phase One Trials:

Phase Two Trials:

Phase Three Trials:

Phase Four Trials:

Who runs a Clinical Trial?

Who can participate in a Clinical Trial?

If you are found ineligible for a study - it is for your own safety!

Why participate in a Clinical Trial?

There are many benefits to be gained from participating in a clinical trial. For patients these include:

In addition to the benefits available from participating in a clinical trial, there are also risks associated with being a participant in a study. These include:

Finally, the patient also has responsibilities e.g. committing to clinic visit schedules, or having to maintain a diary of your condition.

What is the role of the Ethics Committee?

What are the responsibilities of the Sponsors and Researchers?

Commonly Used Research Terms

Research terms that are often used when describing a clinical trial include:

Adverse Events Undesirable side effects that may occur in a clinical trial, which may or may not be a result of taking a study medicine are known as adverse events.

Audits Throughout the duration of a clinical trial and after the trial has been completed, audits may be conducted. These routine checks are performed to ensure that the trial is conducted responsibly and ethically.

Informed Consent Participants must give fully informed voluntary written consent before they are able to take part in a study. Before enrolling in a trial, participants discuss the study with the doctor. This consent form indicates that participants are fully informed and are taking part in the study of their own free will.

Placebo A placebo is an inactive substance that may be given to the control group of patients in a study. This substance looks like a medicine but does not contain any medicine.

Protocol A Clinical Trial Protocol is a detailed description of the design and procedures of a research study. The protocol provides information on what is being researched, why it is being researched, how the research will be conducted and when the research will begin and end.

TGA (Therapeutic Goods Administration) The TGA is an Australian organisation that regulates the testing, manufacture and use of medicines and devices. Medicines and medical devices must be approved by the TGA before they can be made available commercially to the public.

Many factors can influence the effectiveness of a clinical trial and whether the results of the trial are valid. These can include:

Single-blind studies In blind studies either the participant or the doctor is unaware of which treatment they are receiving. In these studies, doctors are aware of the treatment that the patient is receiving.

Double-blind studies In double-blind studies both the doctor and the participant are unaware of which of the listed study treatments the participant is receiving.

Blind and double-blind studies Minimise the chance of biased reporting when participants or doctors discuss the effects of the treatment. Blind and double-blind procedures lead to a more effective study.

Control Groups In clinical trials, there are usually at least two groups. One is an experimental group which is given the new treatment being studied. The other is a control group which is given a standard treatment currently available on the market. If standard treatment is unavailable, the control group is given a placebo (a look-alike pill with no active medicine). Control groups help ensure that the outcomes of the new treatment are not biased by patients' beliefs.

Randomisation Randomised trials are clinical trials where participants are assigned to a treatment group on a random basis. This means that patients are assigned to groups irrespective of their age, gender, medical condition or any other similar factors. These sorts of trials are more reliable.

Sample size This refers to the number of patients involved in the study. Usually, the more people involved in a trial, the more reliable the results of the study will be.